Job Summary: Professional responsible for managing production, quality control, quality management system, pharmacovigilance, and regulatory affairs in the pharmaceutical industry. Key Highlights: 1. Multifunctional role in quality management and pharmaceutical production. 2. Opportunity to work with INVIMA regulations and GMP. 3. Valuable experience in the pharmaceutical industry and regulatory affairs. Job Responsibilities: 1\. **Production and Contract Manufacturing Management** Monitor the status of production orders with contract manufacturers. Coordinate the shipment of samples for physicochemical and microbiological testing. Request, review, and archive certificates of analysis for raw materials, packaging materials, and finished products. Manage technical documentation required for manufacturing processes. Schedule and follow up on meetings with contract manufacturers and laboratories. Update the status of each production order and report any issues to the Technical Director. Track inventories of in-process and quarantined materials. 2\. **Quality Control** Manage the shipment of samples to external laboratories. Request laboratory testing quotations. Consolidate certificates of analysis. Verify documentary compliance of raw materials and packaging materials. Maintain tracking of pending analyses and results. Administer the technical archive of laboratory certificates and reports. Follow up on the resolution of technical issues with suppliers and contract manufacturers. 3\. **Quality Management System** Administer and maintain the Quality Management System up to date. Update the Master Document List. Control versions of procedures, forms, and instructions. Coordinate document dissemination. Monitor document expiration and updates. Maintain organization of physical and digital SGC archives. 4\. **Pharmacovigilance** Keep pharmacovigilance records updated. Periodically review health alerts issued by INVIMA. Organize and archive related documentation. Support follow-up of reported cases. 5\. **Regulatory Affairs** Update regulatory tracking matrices. Follow up on procedures before INVIMA. Consolidate documentation for registrations, modifications, and renewals. Maintain the regulatory product file up to date. Support trademark and sanitary registration tracking. 6\. **PQRS, Non-conformities, and Returns** Register and update PQRS. Follow up on non-conformities until closure. Maintain the returns database up to date. Consolidate investigation evidence and supporting documents. 7\. **Document Management** Organize and safeguard technical and quality documentation. Keep physical and electronic files up to date. Control record storage in accordance with Good Documentation Practices (GDP). Support internal and external audits by providing required documentation. 8\. **Administrative Support** Prepare follow-up reports. Update departmental performance indicators. Coordinate technical department meetings. Manage correspondence with suppliers, laboratories, and contract manufacturers. Support any activity required by the Technical and Quality Directorate. **Education:** Pharmacy Technician (preferred). Quality Control Technician. Pharmaceutical Processes Technician. Final-semester student in Pharmaceutical Chemistry. **Work Experience:** 1–2 years in the pharmaceutical industry. **Experience in:** Quality Management System. GMP and GDP. Document management. Quality control. Contract manufacturer follow-up. Regulatory affairs. Excel proficiency. **Knowledge** INVIMA regulations. Good Manufacturing Practices (GMP). Good Documentation Practices (GDP). ISO 9001\. Handling of certificates of analysis. Document management. Microsoft Office. Workplace: On-site employment
Valentina Rodríguez
Indeed · HR
Valentina Rodríguez
Indeed · HR
